Combination products including a device and a drug formulation for treating diseases and disorders are more commonly used by patients without the need to visit a health professional, a clinic, or a physician. These products are provided as injectables for systemic delivery, or as inhalers for local lung delivery for self-administration. For example, inhalation systems for pulmonary delivery for the treatment of local lung disease or disorders, including chronic obstructive pulmonary disease and asthma, consist of metered dose inhalers consisting of a dry powder formulation and a propellant in the form an aerosol, for example, SYMBICORT®. Drug delivery to the lungs also has been achieved with dry powder inhalers without propellants for the treatment of asthma with, for example, the Advair DISKUS®.
Dry powder inhalers can be breath activated or breath-powered and can deliver drugs by converting drug particles in a carrier into a fine dry powder which is entrained into an air flow and inhaled by the patient. Drugs delivered with the use of a dry powder inhaler are no longer only intended to treat pulmonary disease, but can also be absorbed into the systemic circulation so they can be used to treat many conditions, including diabetes (EXUBERA® and AFREZZA® inhalers).
Dry powder inhalers are made of multiple parts and some mouthpiece designs/prototypes have a tendency to trap and deposit debris at the end of the mouthpiece during storage. Some multiple dose inhalers are designed to include a mouthpiece cover for preventing foreign material to ingress into the mouthpiece, or prevent contamination during inhaler storage between uses. It is thought that some inhaler users may attempt to use the inhaler without removing the mouthpiece cover, which can lead to the mouthpiece cover being inadvertently aspirated by the user during dosing. The potential for inhalation of the cover has led to the need for designing an inhaler mouthpiece cover with improvements to prevent easy dislodgement or removal of the cover, and to prevent inhalation of the mouthpiece cover should the user inadvertently forget to remove it during inhaler use.